Test and Optimization of New Specific MRI Sequences on an Imager Dedicated to Research (SEQ-IRM)

Magnetic Resonance Imaging (MRI) performance depends on equipment performance, equipment maintenance and relevance of MRI sequence used. To optimize MRI performance, it's necessary to develop, optimize, test and validate new acquisition sequences for enhanced diagnosis and therapy monitoring. These new sequences will allow better spatial resolution and specificity while reducing acquisition time.

Study Overview

• Status: Recruiting
• Conditions: Magnetic Resonance Imaging Sequences
• Intervention / Treatment: Device: MRI acquisitions

Detailed Description

The purpose of the present study is to test and optimize, on healthy subjects, specific MRI acquisition sequences firstly developed in a preclinical phase on phantoms (inert objects containing solutions or gels) and animal (Pig, sheep). This study will allow the investigators to define practical acquisition parameters that will allow reproducible results and precise definition of clinically relevant examination protocols for each new developed sequence.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hubert COCHET, MD; Phone Number: +33 (0)557675613; Email: hubert.cochet@chu-bordeaux.fr
• Study Contact Backup: Name: Lorena SANCHEZ BLANCO, MD; Phone Number: +33 (0)557623091; Email: lorena.sanchez-blanco@chu-bordeaux.fr

Study Locations

• France
  • Pessac, France, 33604
    • Recruiting
    • CHU de Bordeaux
    • Contact: Hubert COCHET, MD; Phone Number: +33 (0)557675613; Email: hubert.cochet@chu-bordeaux.fr
    • Contact: Lorena SANCHEZ BLANCO; Phone Number: +33 (0)557623091; Email: lorena.sanchez-blanco@chu-bordeaux.fr
    • Principal Investigator: Hubert COCHET, MD
    • Sub-Investigator: Bruno QUESSON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers (over 18 yo),
• Male or female,
• Affiliated to social security,
• Without any contraindication to MRI exam and who will have signed a written inform consent.

Exclusion Criteria:

• Individuals deprived of liberty,
• Under guardianship or curatorship,
• Persons with known disease which could disturb MRI acquisition or with absolute or relative contraindication to an MRI examination
• Pregnant women,
• Breastfeeding women,
• Women without effective contraception,
• Participants who refused to be informed of the possible discovery of a significant anomaly,
• Persons involved in an interventional study with a drug or an implantable device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRI; MRI exam performed on 200 healthy volunteers	Device: MRI acquisitions; Procedure of the study is an MRI exam without any injection or invasive procedure, that will be performed on the Siemens Magnetom Aera imager of Liryc institute (L'Institut de RYthmologie et modélisation Cardiaque) (Xavier Arnozan site - Bordeaux)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image quality		Day 0
Signal to noise ratio		Day 0
Contrasts between structurally different regions	The values of the signal intensities will be measured in adjacent structures of interest. The difference between these values divided by the noise will be calculated to quantify the contrast-to-noise ratio between these structures. The higher this value is, the better is the sequence in its ability to differentiate these structures from one another.	Day 0
Total acquisition time		Day 0
Qualitative interpretation of image quality to respiratory and cardiac motions	In the presence of improper compensation for cardiac and / or respiratory movements, the images may appear blurred. The qualitative interpretation of image quality will be performed by visual image analysis.	Day 0
Quantitative interpretation of image quality to respiratory and cardiac motions	In the presence of improper compensation for cardiac and / or respiratory movements, the images may appear blurred. The quantitative interpretation of image quality will be performed by a measurement of sharpness of contours between adjacent structures of interest.	Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: L'Institut de RYthmologie et modélisation Cardiaque (IHU LIRYC)
• Investigators: Principal Investigator: Hubert COCHET, MD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Healthy volunteers; Optimization; Test
• Other Study ID Numbers: CHUBX 2017/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No